CHILDRENS MAPAP- acetaminophen tablet, chewable 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major 44-452

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:  If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

 Weight (lb)  Age (yr)Dose
(chewable tablets)*
Under 24 Under 2 Ask a doctor 
24-35 2-3  2 tablets
36-47 4-5  3 tablets
48-59 6-8  4 tablets
60-71 9-10  5 tablets
72-95 11 6 tablets

*or as directed by a doctor

Other information

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-5791-46

Children's
Māpap®

ACETAMINOPHEN
80 mg Chewable Tablets
Pain reliever / Fever reducer

ASPIRIN FREE • IBUPROFEN FREE

AGES 2-6

30 Chewable Tablets

Chew or crush
tablets completely
before swallowing.

Grape Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844      REV0119H45201

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA        M-17       Rev. 02/19
Re-order No. 006446

Major 44-452

Major 44-452

CHILDRENS MAPAP 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5791
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;452
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5791-461 in 1 CARTON12/06/2004
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/06/2004
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0904-5791)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0904-5791)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0904-5791)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0904-5791)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0904-5791)

Revised: 4/2019
Document Id: 68242449-1296-49e6-be17-a2bba7df75a7
Set id: efec6af2-8b26-47f6-88c8-b0a6d69a2d7d
Version: 10
Effective Time: 20190405
 
Major Pharmaceuticals